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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

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DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY Back to Search Results
Model Number 1506-00-007
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Pain (1994); Synovitis (2094); No Code Available (3191)
Event Date 06/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Patient was revised to address suspected loosening of the tibial tray at cement to implant interface.Depuy cement was used.Attune tibial tray was found to be grossly loose.Some pitting was observed on the poly insert.Patient was revised to a stemmed attune fixed bearing revision tray with 2 10mm wedges, and a new poly insert.Doi: (b)(6) 2016; dor: (b)(6) 2019; right knee.
 
Manufacturer Narrative
Udi: (b)(4).(b)(4) was added to capture medical device removal.
 
Event Description
Medical records alleges synovitis.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
ATTUNE FB TIB BASE SZ 7 CEM
Type of Device
ATTUNE IMPLANT : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co
cork
EI 
MDR Report Key8753356
MDR Text Key149797747
Report Number1818910-2019-97442
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295042419
UDI-Public10603295042419
Combination Product (y/n)N
PMA/PMN Number
K101433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1506-00-007
Device Catalogue Number150600007
Device Lot Number8029955
Was Device Available for Evaluation? No
Date Manufacturer Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 7 CEM
Patient Outcome(s) Required Intervention;
Patient Age55 YR
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